This 6-part video series features:
The group discusses their personal experiences around change and configuration management in Med-Tech. Continue reading
FDA and Industry Find Common Ground Driving a Culture of Quality
DATE: March 1, 2017
TIME: 1:30PM Eastern
Industry leaders and regulators are working on the Case for Quality (CfQ) initiative to shift their focus from compliance to quality by giving greater focus and emphasis to critical-to-quality practices throughout the lifecycle of the product.
Would you like to reduce your regulatory burden? Pay dividends in enhanced and predictable product performance? Streamline processes resulting in operational efficiencies? Reduce waste driving to lower costs and improved profitability?
Join Sean Boyd — Deputy Director for Regulatory Affairs, CDRH’s Office of Compliance — Francisco (Cisco) Vicenty — Program Manager (Acting), Case for Quality, FDA — and Daniel R. Matlis — President, Axendia — on March 1st when they’ll discuss the effect the CfQ will have on med-tech manufacturers, healthcare providers, regulators and ultimately the patient.
By: Sandra K. Rodriguez, Market Analyst
Using a Cloud Platform to Connect the Life Science Value Chain
Pharmaceutical, Bio-Tech and Medical Device companies are increasingly adopting cloud platforms to drive effectiveness and efficiency throughout the value chain. These organizations are unifying applications that support the total product lifecycle in a compliant manner, without losing sight of what matters most – product quality.
This shift from disconnected point solutions to a platform approach became clear at the Veeva Systems Global Summit for Clinical, Regulatory, and Quality in Philadelphia on October 17-19, 2016, where I joined over 600 attendees representing 154 companies. Client presentations ranged from start-up to multi-national Life-Science companies including Regeneron, Shire and Johnson & Johnson. A list of presenters can be found here.
Jennifer Goldsmith, Senior Vice President, Veeva Vault kicked off the event by celebrating the five-year birthday of Vault. This was my first time covering the event and I was immediately surprised by the opening keynote delivered by Peter Gassner, CEO at Veeva Systems. He revealed that over the past three years, the company has consistently doubled its customer base across all three of its product offerings – Vault Clinical, Vault Quality and Vault Regulatory. Sessions were offered across all three areas including a track on platforms and a focus on small and mid-size organizations. Continue reading
By: Daniel R. Matlis, President
Improving Healthcare in the Outcome Economy
The Internet of Things (IoT) and the transition to the Outcome Economy were key themes at PTC’s LiveWorx16. The focus on IoT and Product Lifecycle Management (PLM) and the shift to outcome based models, sparked this analysis on the applicability of these trends in our “sick-care system.”
The traditional healthcare model could better be described as “sick-care.” Historically, healthcare has been episodic and reactive — primarily aimed at addressing a malady, illness or injury after it has already happened.
Here are a few examples:
This sick-care approach has it backwards, though. As the refrain goes, an ounce of prevention is worth a pound of cure. Furthermore, sick-care is expensive and unsustainable. But, can we apply the IoT, PLM, and outcome-based models to healthcare? Continue reading